BresoDX1

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December 21, 2022 Bresotec Inc Mehrnaz Tabibi Regulatory and Quality Director 55 York Street Unit 200 Toronto, Ontario M5J 1R7 Canada Re: K220012 Trade/Device Name: BresoDX1 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: November 21, 2022 Received: November 21, 2022 Dear Mehrnaz Tabibi: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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Sincerely, # Rachana Visaria -S Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K220012 Device Name #### BresoDX1 Indications for Use (Describe) BresoDX1 is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients. BresoDX1 records a patient's physiological signals during sleep and sores and hypopneas. BresoDX1 is intended to be used in the home and clinic settings. Type of Use (Select one or both, as applicable) Z Prescription Use (Part 21 CFR 801 Subpart D) □Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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' {3}------------------------------------------------ ### K220012 - 510(k) SUMMARY Submitter Bresotec, Inc. 55 York Street Suite 200 Toronto, Ontario, M5J 1R7 Canada Phone: +1 (647)930-1777 Facsimile: +1 (437)800-1139 Contact Person: Mehrnaz Tabibi Date Submitted: January 4, 2022 Name of Device: BresoDX1 Common or Usual Name: Ventilatory Effort Recorder Classification Name: 21 C.F.R. 868.2375, Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Predicate Device: ACCUSOM manufactured by NovaSom, Inc. (K110486) Referenced Devices: WatchPat200U, manufactured by Itamar Medical, Ltd. (K203839), and AcuPebble SA100 manufactured by Acurable Limited (K210480) #### Device Description BresoDX1 is a lightweight data acquisition system intended for use by Health Care Professional (HCP) as an aid in the diagnosis of moderate to severe sleep apnea for adults. It is suitable for independent use in unattended settings, like in the home, or with minimal assistance in clinic settings. BresoDX1 is to be worn while sleeping and consists of: (1) a BresoSensor which is placed on the patient's suprasternal notch with a disposable BresoSensor Frame (2) a BresoHub, which is located at the bedside; (3) a Nonin WristOx2® pulse oximeter, which is worn on the patient's wrist, where the oximeter sensor is to be placed on the patient's finger; and (4) BresoDX1 software. The BresoSensor and the Nonin WristOx2® pulse oximeter sensor will record patient's tracheal breathing sounds, neck/body position and movement, tracheo-sternal movement, arterial oxyhemoglobin saturation and heart rate overnight during sleep. Recorded data on the BresoSensor and oximeter will be sent to the BresoHub wirelessly via Wi-Fi and Bluetooth for pre-processing and storing. When the patient returns the BresoDX1 system to the health care professional, stored data that had been uploaded will be processed for analysis and sleep study report generation. The generated report will show the following channels: heart rate, SpO2, airflow, respiratory effort, and body position. The health care professional will be able to use the software to review data, edit automated scoring, and re-generate a sleep study report based on the edited scoring for further interpretation. The health care professional will reprocess the device after each use. {4}------------------------------------------------ ## Intended Use / Indications for Use BresoDX I is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients. BresoDX1 records a patient's physiological signals during sleep and scores apneas and hypopneas. BresoDX1 is intended to be used in the home and clinic settings. ## Comparison of Technological Characteristics | Comparison of technological characteristics with predicate and reference devices | | | |----------------------------------------------------------------------------------|--|--| |----------------------------------------------------------------------------------|--|--| | | Bresotec's<br>BresoDX1 | NovaSom's<br>ACCUSOM<br>(Predicate) | Itamar' s<br>WatchPat200U<br>(Reference Device) | AcuPebble SA100<br>(Reference Device) | Comparison | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory<br>Class,<br>Product<br>Code | Class II, MNR | Class II, MNR | Class II, MNR | Class II, MNR | | | 510k # | K220012 | K110486 | K203839 | K210480 | | | Intended<br>Use /<br>Indications<br>for Use | The BresoDX1 is<br>indicated for use as<br>an aid in the<br>diagnosis<br>of moderate to severe<br>sleep apnea in adult<br>patients. The<br>BresoDX1 records a<br>patient's<br>physiological signals<br>during sleep and<br>scores apneas and<br>hypopneas. The<br>BresoDX1 is<br>intended to be used in<br>the home and clinic<br>settings. | The ACCUSOM device<br>is indicated for use in the<br>diagnostic evaluation of<br>adults with possible<br>sleep apnea. The<br>ACCUSOM can score<br>obstructive apneas,<br>which includes mixed<br>apneas.<br>The ACCUSOM device<br>is intended for use in the<br>home and clinic setting. | The Watch-PAT200U<br>(WP200U) device is a<br>non-invasive home care<br>device for use with<br>patients suspected to have<br>sleep related breathing<br>disorders. The WP200U is<br>a diagnostic<br>aid for the detection of<br>sleep related breathing<br>disorders, sleep staging<br>(Rapid Eye<br>Movement (REM) Sleep,<br>Light Sleep, Deep Sleep<br>and Wake), snoring level<br>and body<br>position. The WP200U<br>generates a peripheral<br>arterial tonometry<br>("PAT") Respiratory<br>Disturbance index<br>("PRDI"), Apnea-<br>Hypopnea index<br>("PAHI"), Central<br>Apnea-<br>Hypopnea index<br>("PAHIc"), PAT sleep<br>staging identification<br>(PSTAGES) and optional<br>snoring level and body<br>position discrete states<br>from an external<br>integrated snoring and<br>body position sensor. The<br>WP200U's PSTAGES and<br>snoring level and body<br>position<br>provide supplemental<br>information to its<br>PRDI/PAHI/PAHIc. The<br>WP200U's PSTAGES<br>and snoring level and<br>body position are not | AcuPebble SA100 is<br>indicated to sense, record,<br>and interpret a patient's<br>physiological signals<br>(including respiratory<br>pattern) during sleep for the<br>purpose of pre-screening<br>patients for obstructive<br>sleep apnea (OSA)<br>syndrome. The device is<br>designed for use in home-<br>screening of adults with<br>suspected possible sleep<br>breathing disorders<br>(although it can also be<br>used in clinic). Results are<br>used to assist the healthcare<br>professional in the patient's<br>evaluation.<br>The system is not intended<br>as a substitute for full<br>polysomnography when<br>additional parameters such<br>as sleep stages, limb<br>movements or EEG activity<br>are required. | Substantially equivalent to<br>predicate device.<br>BresoDX1 does not<br>differentiate between<br>obstructive and mixed<br>apneas. This difference<br>does not impact the ability<br>of BresoDX1 to provide<br>information to the user as<br>an aid in the diagnosis of<br>moderate to severe sleep<br>apnea. | | | | | intended to be used as the<br>sole or primary<br>basis for diagnosing any<br>sleep related breathing<br>disorder, prescribing<br>treatment, or<br>determining whether<br>additional diagnostic<br>assessment is warranted.<br>PAHiC is indicated for use<br>in patients 17 years and<br>older. All other<br>parameters are indicated<br>for 12 years and older. | | | | User<br>Population | Home and clinic<br>setting | Home and clinic setting | A non-invasive home care<br>device | For use in home-screening<br>(although it can be used in<br>clinic) | Substantially equivalent to<br>predicate device. | | Sensors | -Microphone in<br>BresoSensor placed<br>on the suprasternal<br>notch<br>-Oximeter sensor<br>placed on finger -<br>Three-dimensional<br>accelerometer in<br>BresoSensor placed<br>on suprasternal notch | -Breath Sensor (sensing<br>microphone and ambient<br>noise microphone)<br>placed under the nose<br>-Oximeter finger sensor<br>placed on the finger<br>- Chest Sensor located<br>on the chest. | -uPAT finger<br>probe placed on the<br>finger<br>-Actigraphy on the wrist<br>- (optional) External<br>SBP/RESBP chest sensor<br>(microphone, three-<br>dimensional<br>accelerometer) placed on<br>the chest right under the<br>sternal notch | -Microphone placed on the<br>neck above the suprasternal<br>notch | Substantially Equivalent to<br>predicate device.<br>In addition, BresoDX1 and<br>reference device uses three-<br>dimensional accelerometer. | | Channels | Airflow, respiratory<br>effort, tracheal breath<br>sounds tracheo-<br>sternal movement,<br>pulse rate, SpO2,<br>body position | Airflow, respiratory<br>sounds, pulse rate, SpO2,<br>snoring level | PAT, pulse rate, oximetry,<br>actigraphy, snoring, body<br>position, chest movement | Sounds (Cardiac features,<br>respiratory features,<br>movement features) | Substantially Equivalent to<br>predicate device.<br>BresoDX1 does not provide<br>the output of snoring levels.<br>Snoring is optional for<br>HSAT and is not essential<br>for the diagnosis of sleep<br>apnea.<br>The difference of system<br>output between BresoDX1<br>with its predicates does not<br>raise any uncertainty of<br>safety, effectiveness, and<br>efficacy. | | Portability | Yes (wearable) | Yes (wearable) | Yes (wearable) | Yes (wearable) | Identical to predicate<br>device. | | Data<br>Download | Transfer through<br>wireless connection | Transfer through<br>wireless connection | Transfer through USB<br>connection | Transfer through wireless<br>connection | Substantially equivalent to<br>predicate device. | | Size and<br>Weight of<br>sensor | BresoSensor:<br>17.4×38.7×35.5 mm<br>17g | Patient Module :<br>100.3×71.9×29.5 mm<br>116.2 g | Chest sensor:<br>1.3inch (32mm) diameter<br>12g | 29.5mm diameter × 16mm<br>height<br>7g | Different but difference in<br>size and weight do not raise<br>safety or effectiveness<br>question. | | Power<br>Source | BresoHub: wall<br>mount power adaptor<br>BresoSensor:<br>Lithium-ion<br>rechargeable battery<br>Oximeter: 2 × 1.5V<br>Alkaline AAA<br>battery | Patient Module:<br>Rechargeable battery<br>operated | One OTS 1.5V Alkaline<br>AAA battery OR<br>One rechargeable AAA<br>1.2V Nickel-metal<br>hydride battery<br>rechargeable (NiMH)<br>battery | Rechargeable lithium<br>polymer battery | Different but difference in<br>power source do not raise<br>safety or effectiveness<br>question. | | Indicators | Visual indicators<br>LEDs on<br>BresoSensor and<br>BresoHub.<br>Indicators on<br>BresoHub Web<br>Interface | Audio and visual<br>indicators | Visual indicator – error<br>messages | N/A | Different. BresoDX1 does<br>not have audio indicators,<br>but it has visual indicators.<br>This difference does not<br>raise safety or effectiveness<br>question. | | Sterilization | Nonsterile | Nonsterile | Nonsterile | Nonsterile | Identical. | {5}------------------------------------------------ {6}------------------------------------------------ BresoDX1 and its predicate device, ACCUSOM, utilize the same technology to monitor key signals. Both devices use a microphone to detect a patient's breathing pattern, and a pulse oximeter to determine a patient's arterial oxyhemoglobin saturation and pulse rate. BresoDX1 processes recorded sound data and accelerometer data using a proprietary software algorithm to estimate a subject's airflow changes and respiratory effort and to generate the corresponding waveforms. ## Software BresoDX I Software collects and stores the data during a test. Data will be uploaded to the cloud. BresoDX1 Software will process and analyze the data to generate a test report. The test report and the data will be reviewed and interpreted by a Health Care Professional. Some functionalities require connectivity with the cloud system. Those functionalities are as follows: - i. Data upload - ii. Data Storage - iii. Data Analysis - User and Study Management iv. - V. Study Editor - vi. Study Report Generator The BresoDX1 software is developed according to Medical Device Software/ Software lifecycle processes: IEC 62304:2006/A12016. Also, BresoDX1 software is developed according to Information security, cybersecurity and privacy protection, Information security controls: ISO/ IEC 27002: 2022. ## Performance Data A series of safety and functional testing was performed to confirm that BresoDX1 meets the requirements of the relevant standards. These tests include electrical safety testing according to IEC 60601-1:2005+A1:2012, CAN/CSA-C22.2 No. 60601-1:2014, ANSI/AAMI ES60601-1:2005/A1:2012, home healthcare environment testing according to IEC 60601-1-11:2015, usability according to IEC60601-1-6:2010+A1:2013, application of usability engineering to medical devices according to IEC 62366-1:2015 and IEC 62366-1:2015/COR1:2016, EMC testing according to IEC 60601-1-2:2014, FCC part 15 tests. Biocompatibility of the patient contacting components (BresoDX1 plastic housing, tape on the BresoSensor Frame) in direct contact with patient's healthy closed skin for up to 8 hours were tested in accordance with ISO10993-1 and FDA's corresponding guidance document, Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility tests for these patient contacting components of the subject device complaint with the following standards: {7}------------------------------------------------ - · Cytotoxicity per ISO 10993-5 (2009) - · Irritation per ISO 10993-10 (2010) - · Skin sensitization per ISO 10993-10 (2010) Bench performance tests were performed to demonstrate that the system meets its performance requirements by verifying the device precision and evaluating the inter-device and intra-device repeatability and reproducibility in detecting sleep apnea events and evaluating the impact of environmental noises on the device performance. Oximetry input integration validation test was performed to evaluate the accuracy of the integration of Nonin WristOx2® Model 3150 BLE pulse oximeter with the BresoDX1 system. All tests confirmed that the subject device meets the pre-determined acceptance criteria and the requirements of the relevant standards. Clinical performance testing was performed in compliance with the recognized consensus standard ISO 14155:2020 (Clinical investigation of medical devices for human subjects-Good clinical practice to evaluate the capability of BresoDX1. A prospective, single-arm, multiple-site, blinded study was performed to validate the BresoDX1 in comparison with in-laboratory polysomnography (PSG). The study involved overnight recording of the BresoDX1 and clinical PSG in the sleep laboratory, simultaneously. One hundred and sixty-four (164) subjects were evaluated. Based on the clinical performance as documented in the pivotal clinical study, the BresoDX1 has a safety and effectiveness profile that is similar to the predicate device. The BresoDX1 diagnosis accuracy from the clinical study is summarized as follows: | | REIb based diagnosis*<br>n/Total, (95% Confidence Interval) | |---------------------------|-------------------------------------------------------------| | Sensitivity | 69/78, 88.5% (79.2%, 94.6%) | | Specificity | 73/86, 84.9% (75.5%, 91.7%) | | Positive Predictive Value | 69/82, 84.1% (74.4%, 91.3%) | | Negative Predictive Value | 73/82, 89.0% (80.2%, 94.9%) | * REIb is the total number of respiratory events scored × 60 divided by monitoring time (in minutes). The diagnostic criteria were based on the established threshold, AHI cut-off 15. The REIn accuracy from the clinical study is summarized as follows: Correlation between REIb and AHI(PSG) is 0.93 AHI(PSG) = $1.033 × REI_b - 0.0705$ REIb is Respiratory Event Index calculated by BresoDX1 software and AHI(PSG) is Apnea and Hypopnea Index calculated by clinical PSG. The Oxygen Desaturation Index (ODI) accuracy from the clinical study is summarized as follows: Correlation between ODI(BresoDX1) and ODI(PSG) is 0.95 ODI(PSG) = $1.334 × ODI_{(BresoDX1)} + 5.317$ ODI(BresoDX1) is Oxygen Desaturation Index calculated by BresoDX1 and ODI(PSG) is Oxygen Desaturation Index calculated by clinical PSG. {8}------------------------------------------------ ### SpO2 and Pulse Rate Measurement Accuracy The accuracy of the Nonin 3150BLE SpO2 and pulse rate values in comparison to the co-oximeter samples measured over the SpO2 range of 70% - 100% are validated in accordance with Medical Electrical Equipment- ISO 80601-2-61:2017 Sub-clauses 201.12.1.103 & 201.12.1.104 Pulse Rate and SpO2 accuracy. Accuracy data is calculated using the root-mean-square ($A_{rms}$ value) for all data points using the following RMS figure of merit calculation: $$A_{rms} = \frac{\sqrt{\Sigma_{i=1}^n (X_i - X_{Ri})^2}}{n}$$ $X_i$ is the oximeter 4 beat average reading and $X_{Ri}$ is the Oxitest setting at the corresponding sample time. The accuracy of SpO2 ($A_{rms}$ value) is ±2% (non-motion, low perfusion) ±3% (motion) within the SpO2 range of 70% - 100%. The accuracy of pulse rate ($A_{rms}$ value) is ±3% (motion, non-motion, low perfusion) within the pulse rate range of 18-300 BPM (beats per minutes). ## Conclusions BresoDX1 has the same intended use and similar indications for use, technological characteristics, and principles of operation as its predicate device (K110486). Performance data demonstrated substantially equivalent performance as the ACCUSOM. Thus, BresoDX1 is substantially equivalent to the predicate device.